A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
研究概览
简要总结
This phase II trial is studying how well eribulin mesylate works in treating patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
详细描述
PRIMARY OBJECTIVES:
I. Determine the frequency of objective response (complete and partial responses) in patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with E7389 (eribulin mesylate).
SECONDARY OBJECTIVES:
II. Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum sensitivity (yes vs no).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
- •Recurrent disease after ≥ 1 prior therapy, meeting 1 of the following criteria:
- •Platinum-resistant disease (progression-free interval < 6 months)
- •Platinum-sensitive disease (progression-free interval ≥ 6 months)
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mmby conventional techniques OR ≥ 10 mm by spiral CT scan
- •No known brain metastasis
- •Life expectancy > 2 months
- •ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •WBC ≥ 3,000/mm^3
- •Bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatine normal OR creatinine clearance ≥ 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •Stage IA or IB endometrial cancer within the past 5 years allowed provided patient is considered disease free
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to E7389
- •No HIV positivity
- •No ongoing or active infection
- •No cardiac arrhythmia
- •No unstable angina pectoris
- •No symptomatic congestive heart failure
- •No psychiatric illness or social situations that would preclude study compliance
- •No other uncontrolled intercurrent illness
- •See Disease Characteristics
- •Recovered from effects of recent surgery, radiotherapy, or chemotherapy
- •No more than 2 prior cytotoxic therapies with no more than 1 non platinum, non taxane regimen
- •No prior E7389
- •More than 14 days since prior hormonal therapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- •More than 4 weeks since prior radiotherapy
- •No concurrent antitumor hormonal therapy
- •No other concurrent investigational agents
- •No other concurrent anticancer agents or therapies
- •No granulocyte colony-stimulating factors during the first course of study therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy)
Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: eribulin mesylate (Drug)
结局指标
主要结局
Objective Response to Treatment With Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer.
时间窗: up to a total of a year
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Toxicity Profile of Eribulin Mesylate in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer(From the time of their first treatment with eribulin mesylate)